Lung Recruitment Maneuvers for Postoperative Atelectasis Prevention After Idiopathic Adolescents' Scoliosis Correction
Primary Purpose
Postoperative Atelectasis, Lung Recruitment, Scoliosis; Adolescence
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional lung recruitment
ultrasound- guided lung recruitment
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Atelectasis
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for elective correction of AIS
- aged between 10 and 25 years old
- ASA class I & II
- both genders
Exclusion Criteria:
- Morbidly obese patients
- patients with previous thoracic surgery
- upper or lower airway infection within 2 weeks before the surgery
- abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia
Sites / Locations
- Faculty of medicine, Tanta universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
conventional
ultrasound- guided
Arm Description
Outcomes
Primary Outcome Measures
the incidence of atelectasis
the incidence of postoperative atelectasis in post-anaesthesia care unit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05325463
Brief Title
Lung Recruitment Maneuvers for Postoperative Atelectasis Prevention After Idiopathic Adolescents' Scoliosis Correction
Official Title
Safety and Efficacy of Ultrasound-guided Lung Recruitment Maneuvers for Prevention of Postoperative Atelectasis After Surgical Correction of Idiopathic Adolescent Scoliosis. A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hypothesized that an ultrasound-guided lung recruitment maneuvers would be more effective in preventing postoperative atelectasis than conventional alveolar recruitment after surgical correction of idiopathic adolescent scoliosis.
Detailed Description
In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragm dysfunction induced by general anesthesia is one of the most important factors in the genesis of regional losses of lung aeration; the mass of the abdominal organs pushes the diaphragm cranially compressing the lungs in the most dependent areas. Such regional lung collapse may range from slight loss of aeration to complete atelectasis.
Scoliosis correction surgery for adolescent idiopathic scoliosis (AIS) is effective in preventing deterioration of lung function caused by disease progression, and improving lung volume over the long term. However, complications of the respiratory system and pulmonary dysfunction may occur in the immediate postoperative period. General anesthesia (GA) and positive pressure ventilation can cause decreased lung volumes, expiratory flow rates, and oxygenation after surgery as a result of positive pressure ventilation, partial recovery of respiratory muscle, pain, and immobilization.
Lung ultrasound has been gaining consensus as a noninvasive, radiation-free tool for diagnosing various pulmonary diseases in adult and pediatric patients. Evidence supporting lung ultrasound use is expanding beyond emergency and critical care settings to perioperative care.
It has been reported that lung ultrasound (LUS) at a patient's bedside immediately following surgery can be useful for diagnosing respiratory complications. LUS has proven to be a valuable bedside diagnostic tool for pneumothorax, with high sensitivity and specificity (78.6% and 98.4%, respectively), and a higher rate of detecting abnormalities such as lung alveolar consolidation and pleural effusion than bedside chest X-ray or physical examination. LUS has also been used to diagnose anesthesia-induced atelectasis in pediatric patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atelectasis, Lung Recruitment, Scoliosis; Adolescence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional
Arm Type
Experimental
Arm Title
ultrasound- guided
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
conventional lung recruitment
Intervention Description
The recruitment maneuver will be performed by pressure controlled mode maintaining a steady airway pressure of 15 cmH2O, with 5 cmH2O increments in PEEP until a peak pressure of 30 cmH2O will be achieved. Each PEEP level will be maintained for 5 sec. The peak airway pressure will be maintained for 10 sec or five breaths and subsequently reduced, followed by maintenance with the previous ventilator settings.
Intervention Type
Procedure
Intervention Name(s)
ultrasound- guided lung recruitment
Intervention Description
The recruitment maneuver will be performed under ultrasound guidance until no collapsed lung area was visible. The strategy to increase the airway pressure will be the same as that for the conventional maneuver, although the maximal pressure limit was 40 cmH2O.
Primary Outcome Measure Information:
Title
the incidence of atelectasis
Description
the incidence of postoperative atelectasis in post-anaesthesia care unit
Time Frame
postoperative first 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for elective correction of AIS
aged between 10 and 25 years old
ASA class I & II
both genders
Exclusion Criteria:
Morbidly obese patients
patients with previous thoracic surgery
upper or lower airway infection within 2 weeks before the surgery
abnormal preoperative chest x-ray findings including atelectasis, pneumothorax, pleural effusion or pneumonia
Facility Information:
Facility Name
Faculty of medicine, Tanta university
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tarek Mostafa
Phone
020403332033
Email
dr.tarek311@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lung Recruitment Maneuvers for Postoperative Atelectasis Prevention After Idiopathic Adolescents' Scoliosis Correction
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